510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970159Substantially Equivalent

Flex-Neck Pd Catheter

Janin Group, Inc., Aurora IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970159 is the FDA 510(k) clearance record for FLEX-NECK PD CATHETER, a class II device, cleared for Janin Group, Inc. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 5 510(k) clearances for Janin Group, Inc., from to . As of , FDA records show one recall naming K970159.

Clearance record

Decision date
Received
(232 days to decision)
Product code
FJS Catheter, Peritoneal, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Janin Group, Inc. 615 Enterprise St., Aurora IL
510(k) summary
Summary
Third party review
No

Clearances, product code FJS

Trailing 12 months

FDA records hold no clearances under product code FJS in the trailing twelve months.

FDA records show no clearances under product code FJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260